Ravicti Side Effects: Diarrhea, Flatulence, Headache

What are the side effects of Ravicti, the newly approved drug for urea cycle disorders (UCD)? According to the U.S. Food and Drug Administration, Ravicti has the following side effects: diarrhea, flatulence, and headache. We’re pretty sure that those are only the most common side effects and that we will eventually know the lesser known, less common side effects once we agency releases the prescribing information for the drug.

Check back later for updates.

For the time being, here are things you might be interested to know about the drug which we culled from the FDA media release:

  • Ravicti is in liquid form and is taken three times a day with meals.
  • The drug is only for patients ages 2 years and older.
  • Ravicti must be used with a protein-restricted diet and, in some cases, dietary supplements.
  • The major study supporting Ravicti’s safety and effectiveness involved 44 adults who had been using Buphenyl, another drug approved to control UCDs. Patients were randomly assigned to take Buphenyl or Ravicti for two weeks before being switched to the other product for an additional two weeks. Blood testing showed Ravicti was as effective as Buphenyl in controlling ammonia levels. Three additional studies in children and adults provided evidence supporting the long-term safety and effectiveness of Ravicti in patients 2 years and older.

Says Donna Griebel, M.D., director of the Division of Gastrointestinal and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research, about the drug: “Ravicti provides another treatment for chronic management of urea cycle disorders, a group of life-threatening conditions. The approval of this new therapeutic option demonstrates FDA’s commitment to providing treatments for patients suffering from rare diseases.”